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FDA 510(k)

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04

K-Number: K991866 · 1999-08-02

ApplicantA.P. Total Care, Inc.
Decision Date1999-08-02
Product CodeCIG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-08-02 under 510(k) number K991866. The device is classified under product code CIG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04?

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 is a medical device that received FDA 510(k) clearance on 1999-08-02. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K991866.

When did BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 receive FDA 510(k) clearance?

BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 received FDA 510(k) clearance on 1999-08-02, under 510(k) number K991866.

Who is the listed applicant for BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04?

The FDA 510(k) record lists A.P. Total Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04?

The FDA product code for BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04 is CIG.

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Other records listing A.P. Total Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991246FRUCTOSAMINE, MODEL FR 106-01K991761MAGNESIUM PRODUCT NO'S, 112-01, 112-02K991762ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02K991664LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01K991665HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01K991867INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02

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Related Devices (Code: CIG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251998Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223078Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc.K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.K223324Total Bilirubin2Abbott Ireland Diagnostics DivisionK190807VITROS XT Chemistry Products TBIL-ALKP SlidesOrtho-Clinical Diagnostics, Inc.K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1Elitechgroup

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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